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| Bidiphar's Small Volume Sterile Pharmaceutical Factory Project is under construction in Nhon Hoi Industrial Park - Area A. |
At the recent 2025 Annual General Meeting of Shareholders, Ms. Pham Thi Thanh Huong, General Director of Binh Dinh Pharmaceutical and Medical Equipment Joint Stock Company (Bidiphar) said that the Small Volume Sterile Drug Manufacturing Plant Project is in the process of construction and equipment procurement ( in 2025, more than 570 billion VND will be disbursed). It is expected that the project will complete equipment installation by the end of 2025.
According to Ms. Huong, the 2-building block, of which the factory building has been completed, the QA and QC center building block is under construction; the IT system is in the process of signing contracts...
Regarding the assessment and licensing of the factory to meet GMP-WHO standards, Bidiphar is expected to complete it by the end of 2026; GMP-EU standards are expected in 2028. Bidiphar is allowed to start operating the small-volume sterile drug factory after the Drug Administration of Vietnam ( Ministry of Health ) grants the license, expected from 2027.
Regarding the shareholders' opinion that the factory is behind schedule, Bidiphar's General Director said that the Board of Directors of the Company is very interested in investing in the project "because if the company does not manage it tightly, it is easy to lose money during the investment process".
The project is slow, Ms. Huong explained that the procurement process according to GMP - EU standards is very different from the normal procurement process from building the procurement unit price, then transferring to the consulting unit to check whether it meets or not, then moving to the bidding stage. Then comes the process of interacting and working with contractors, some bidding packages last up to 10 months.
“The principle is to ensure quality requirements and meet GMP - EU requirements, this is the most difficult requirement,” said Ms. Huong.
Bidiphar General Director emphasized that meeting GMP – EU requirements is “not simple at all”, from configuration, supplier control to design documents to the following stages, a very high requirement of documents. Up to now, the stages have been basically completed, Bidiphar has deployed bidding, the negotiation of the bank to sign the bidding package has also been completed.
“The time is slow, but we think it is necessary to ensure project quality as well as investment efficiency, avoid loss, wrong purchase, and purchase of bad products,” Ms. Huong affirmed.
Currently, Bidiphar is in the negotiation phase with suppliers to implement the contract. The contract notes that the installation will be completed this year; an appraisal will be conducted in 2026.
For the Cancer Treatment Drug Manufacturing Plant (over 1.5 hectares, total investment of 500 billion VND, inaugurated on December 2, 2023), this plant has 2 production lines: injection line (3 million products/year) and pill line (70 million products/year).
Bidiphar's General Director said that the injection drug production line has achieved GMP-WHO certification and is currently in the process of completing the quality assurance system to meet GMP-EU standards, expected to be completed in 2028-2029.
For the tablet production line, Bidiphar has also achieved GMP-WHO certification; the company is in the process of submitting registration documents for products manufactured on this production line (4 documents have been submitted in 2024) and will continue to do so in the following years.
The project's objective is to invest in building a new factory to produce injections, eye drops and other sterile medicines according to GMP-EU standards with a capacity of 120 million products/year (equivalent to 1,600 tons/year).
Regarding progress, from the fourth quarter of 2023 to the first quarter of 2025, the Project will start construction of the factory and phase 1 auxiliary works including a small-volume sterile drug factory; QC, QA, R&D center; canteen; technical cluster, transformer station, garage, and guard house.
From the first quarter of 2028 to the fourth quarter of 2028, the Company will recruit, train personnel, and officially operate the factory; in 2030, the Company will start construction of the factory and phase 2 auxiliary works, which is the office building block.
Source: https://baodautu.vn/bidiphar-du-an-nha-may-san-xuat-thuoc-vo-trung-se-hoan-thanh-lap-dat-trong-nam-2025-d274738.html
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